GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 8/11/2018 |
| Start Date: | August 2008 |
| End Date: | February 2020 |
GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients With Patent Foramen Ovale (PFO) - The Gore REDUCE Clinical Study
The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE®
HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder plus antiplatelet medical
management is safe and effective and reduces the risk of recurrent stroke or
imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical
management alone in patients with a PFO and history of cryptogenic stroke or
imaging-confirmed TIA.
A co-primary objective is to demonstrate that medical management plus closure with the study
device reduces the risk of new brain infarct compared to medical management alone.
HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder plus antiplatelet medical
management is safe and effective and reduces the risk of recurrent stroke or
imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical
management alone in patients with a PFO and history of cryptogenic stroke or
imaging-confirmed TIA.
A co-primary objective is to demonstrate that medical management plus closure with the study
device reduces the risk of new brain infarct compared to medical management alone.
Inclusion Criteria:
- Presence of cryptogenic ischemic stroke or TIA of presumed embolic infarction verified
by a neurologist within 180 days prior to randomization
- Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble
study utilizing transesophageal echocardiography (TEE), demonstrating spontaneous
right-to-left shunting or right-to-left shunting during Valsalva maneuver.
- Absence of an identifiable source of thromboembolism in the systemic circulation
- No evidence of a hypercoagulable state
- Note: Additional Inclusion Criteria may apply
Exclusion Criteria:
- Other co-morbidities including, but not limited to, mural thrombus, dilated
cardiomyopathy, atrial fibrillation/flutter, cardiac prosthetics (valves), mitral
valve stenosis, aortic dissection, significant atherosclerosis, vasculitis,
pre-existing neurologic disorders, multiple sclerosis, arteriovenous malformations,
prior intracranial hemorrhage, severe central nervous system (CNS) disease, severe
disability related to prior stroke, and autoimmune disorders that would increase the
risk of mortality or morbidity above what is typical for the treatment
- Previous Myocardial Infarction
- Active infection that cannot be treated successfully prior to randomization
- Sensitivity or contraindication to all proposed medical treatments
- Pregnancy or intent on becoming pregnant through 24-months after randomization
- Indications outside the parameters accepted for placement of the GORE® HELEX® Septal
Occluder / GORE® Septal Occluder, including extensive congenital cardiac anomalies and
defect diameter estimated to be > 18mm
- Atrial septal anatomy that is expected to necessitate placement of more than one GORE®
HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder
- Need for concomitant procedure(s) that may confound detection of adverse events
related to device placement
- Note: Additional Exclusion Criteria may apply
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